Accuracy of Ultrasonography in Breast Implant Rupture Diagnosis

Systematic Review and Meta-Analysis

Ana Cristina Lacerda Macedo, Ph.D.; George Carvalho, M.S.; Maria L. R. Uggioni, B.Sc.; Daniela V. Bavaresco, Ph.D.; Carla S. Simon, B.Sc.; Mateus Cruz; Fábio Silva, B.Sc.; Maria I. Rosa, Ph.D.

Disclosures

Plast Reconstr Surg. 2021;148(5):939-947. 

In This Article

Abstract and Introduction

Abstract

Background: Breast augmentation is the most common aesthetic operation performed in the United States and worldwide; 1,862,506 breast augmentation procedures were performed in 2018, an increase of 27.6 percent compared to 2014 data.

Methods: In the present study, the authors performed a systematic review to identify the accuracy of ultrasonography for diagnosing breast prosthesis rupture. Studies in which the ultrasound diagnostic test was compared to a surgical finding as a reference standard were reviewed.

Results: As a result, 20 primary studies were included in the analyses, with a total of 1987 patients and 3297 prostheses. The use of ultrasound for diagnosis of breast prosthesis rupture presented the following results: pooled sensitivity, 73.7 percent (95 percent CI, 70.2 to 77.1 percent); pooled specificity, 87.8 percent (95 percent CI, 86.5 to 89.0); area under the receiver operating characteristic curve, 0.7762; diagnostic odds ratio, 11.04 (95 percent CI, 5.79 to 21.08).

Conclusion: This study supports that ultrasound of breast prostheses is an adequate tool in the diagnosis of rupture.

Introduction

Breast augmentation is the most common aesthetic operation performed in the United States, reaching 329,914 procedures in 2018, with an increase of 15.2 percent compared to 2014.[1] Worldwide, 1,862,506 breast augmentation procedures were performed in 2018, an increase of 27.6 percent during the same period.[2] This procedure has been performed on women younger than 34 years in 56.7 percent of cases,[2] which means that they potentially have many years of life with the prosthesis. The most common indication for breast implants is augmentation, followed by reconstruction, usually after breast cancer treatment.[3] In the United States, the silicone smooth prosthesis is used the most, mainly from the following three manufacturers: Sientra (Santa Barbara, Calif.), Mentor (Irvine, Calif.), and Allergan (Irvine, Calif.).[4,5] In contrast, textured implants are more common in Europe.[4,5] Silicone-filled, saline-filled, and polyvinylpyrrolidone-hydrogel–filled implants are on the market. Silicone breast implants from the French manufacturer Poly Implant Prothèse were recalled from the European market after identification that the implants contained non–medical-grade silicone filler. In December of 2011, facing a large increase in the reported rupture rate and a possible cancer risk, in France, it was recommended that explantation of Poly Implant Prothèse devices be considered, regardless of their condition.[6] Therefore, there has been an increase in explantation procedures in the past decade, which has contributed to the present study.

Besides this specific episode, reoperation for breast implant explantation mainly occurs when women desire an aesthetic change and have signals and symptoms of capsular contracture and implant bleeding or rupture, such as pain, palpable masses, and asymmetry. The leading theory on the pathogenesis of capsular contracture includes the alignment and contraction of fibroblasts within the capsule that forms around a breast implant.[5] The ruptured implants can be differentiated as "intracapsular" and "extracapsular." An intracapsular rupture is defined as a rupture of the implant shell, with an intact inflammatory capsule around the implant. By contrast, an extracapsular rupture is defined as a rupture of both structures (shell and capsule).[7]

The rupture can be frequently asymptomatic, as the silicone released by the implant remains confined within the fibrous capsule surrounding the implant itself.[8] This justifies the importance of diagnostic imaging for predicting the integrity of the prosthetic implant. The U.S. Food and Drug Administration recommends ultrasound or magnetic resonance imaging surveillance of silicone implants 5 to 6 years postoperatively and every 2 years thereafter to assess for integrity/rupture.[9] Imaging is a financial burden to patients, mainly because a tool such as magnetic resonance imaging is costly, and therefore previous studies have pointed out that an initial assessment with ultrasound is an optimal alternative under economic analysis.[10] The aim of this systematic review is to define whether ultrasound has satisfactory accuracy in the screening of breast implant ruptures, beside the fact that it is an accessible tool.

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